CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 586 enrolled
Drug / intervention
Observational testother
Likely dose
Not stated in record
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Search/NCT04168814
NCT04168814N/ACompleted

An Observational Study of the Nutritional Status in Locally Advanced or Metastatic Solid Cancer Patients While Receiving Immunotherapy in Spain: the NutriOncoSearch (NOS) Study

Universidad Pontificia Comillas·observational·Posted Nov 19, 2019·Updated May 23, 2022

In Brief

An observational study evaluating Observational test for Malnutrition and 3 related conditions. Completed, enrolled 586 participants across 11 sites.

Detailed Summary

Malnutrition is a common medical problem in oncology patients. It is well known that the presence of malnutrition negatively affects patients' evolution and their quality of life, increasing the incidence of infection, hospital stay, and mortality. The new knowledge of cancer biology has made it possible to know the mechanisms of cancer progression. New treatments have been developed thanks to this knowledge including molecular target treatments aimed at these cancer mechanics and to reverse the antitumor capacity of the immune system. However, these treatments have different toxicities than classic and anachronistic treatments such as chemotherapy and radiotherapy, including alterations in glucose metabolism, endocrinopathies, rhabdomyolysis, etc. that can alter both the patient's nutritional status and quality of life. Additionally, a deficient nutritional status can have an impact on the intestinal microbiota, compromising the efficacy of the new antitumor treatments. The principal objective of this study is to characterize the nutritional status of the cancer outpatient receiving immunotherapy through a screening performed in Hospital consultations in Spain. Secondary Endpoints are (a). To describe the percentage of patients that receive nutritional counseling or nutritional support (enteral and/or parenteral nutrition) among those diagnosed as malnourished or at risk. And (b) to categorize the percentage and descriptive characteristics of cancer patients with mild, moderate, or severe malnutrition that goes to a hospital consultation in Spain and describe the percentage and descriptive characteristics of patients with malnutrition according to sociodemographic and clinical characteristics.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 19, 2019
Enrollment StartJun 10, 2020
Primary CompletionOct 9, 2020
Study CompletionDec 15, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.6 years ago

Interventions

Observational testother

Nutritional risk (NutriScore), based on weight, weight loss, tumor location, and treatment, Nutritional status (VGS, Global Subjective Assessment Valoración Global Subjetiva, in Spanish), ECOG performance status; nutritional therapy (oral nutritional supplements, enteral nutrition, parenteral nutrition, dietary advice); type of treatment: chemo, type of chemo, adjuvant, neoadjuvant, palliative, curative endocrine therapy, targeted therapy +-immunotherapy vs QQT/RT therapy; cancer site. Covid-19 diagnosis.